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Second STOP After Pioglitazone Priming in CML Patients (PIO2STOP)

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ClinicalTrials.gov Identifier: NCT02889003
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Pr Philippe ROUSSELOT
Information provided by (Responsible Party):
Dr Noémie DE GUNZBURG, Versailles Hospital

Brief Summary:

Single-center study, prospective, phase II trial.

The study objectives are :

  • To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation.
  • To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain < MR4.5 with the combination PIO and TKI administered for at least 6 months.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia (CML) Drug: Pioglitazone + TKI Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Study of Pioglitazone and Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia Patients After Failure of a First TKIs Discontinuation Attempt in Order to Prepare a New Stop
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: CML patients following molecular response loss Drug: Pioglitazone + TKI



Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 24 months after inclusion ]
  2. Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation. [ Time Frame: Up to 24 months after inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. CML in any phase. patient in MR4
  2. Loss of MMR following a first or subsequent TKI discontinuation trial.
  3. Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
  4. Age >18 years.
  5. Serum bilirubin <1.5 x upper limit of normal values.
  6. AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values.
  7. Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence.
  8. Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period.
  9. Signed informed consent.
  10. Be able and willing to comply with study visits and procedures

Exclusion Criteria:

  1. Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1.
  2. Loss of CHR.
  3. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment.
  4. Prior allogeneic hematopoietic stem cell transplantation.
  5. Patient requiring anti-diabetic medications to manage hyperglycemia.
  6. Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment.
  7. Hepatic insufficiency
  8. History of bladder cancer.
  9. Diagnosed hematuria.
  10. Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria)
  11. Known history of macular edema.
  12. Known history of ABL1-domain mutation associated with resistance to the discontinued TKI.
  13. Known allergy to PIO.
  14. Pregnant or breastfeeding.
  15. Use of TZD within 28 days prior to enrollment.
  16. Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug.
  17. Uncontrolled peripheral edema (2+ or more) of any etiology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889003


Contacts
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Contact: Noémie DE GUNZBURG, Investigator coordinator ndegunzburg@ch-versailles.fr
Contact: Amina CATTENOY, Project Manager acattenoy@ch-versailles.fr

Locations
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France
Centre Hospitalier de Versailles Recruiting
Le Chesnay, France, 78150
Contact: Noémie DE GUNZBURG       ndegunzburg@ch-versailles.fr   
Sub-Investigator: Philippe ROUSSELOT         
Hôpital Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Ali TURHAN       ali.turhan@aphp.fr   
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Contact: Viviane DUBRUILLE       viviane.dubruille@chu-nantes.fr   
CHU de Rennes Not yet recruiting
Rennes, France, 35033
Contact: Martine ESCOFFRE-BARBE       Martine.escoffre-barbe@chu-rennes.fr   
Sponsors and Collaborators
Versailles Hospital
Pr Philippe ROUSSELOT

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Responsible Party: Dr Noémie DE GUNZBURG, Investigator coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02889003     History of Changes
Other Study ID Numbers: P16/05_PIO2STOP
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs